Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study

January 15, 2026 updated by: Marcelo Hisano, University of Sao Paulo General Hospital

A Comparative Analysis of Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Genital Prolapse: a Prospective Randomized Non-inferiority Study.

The goal of this study is to compare vaginal mesh surgery with abdominal robotic-assisted mesh surgery for the treatment of genital prolapse in women. The main questions it seeks to answer are:

  • Is the objective cure rate for vaginal mesh surgery non-inferior to that of the abdominal approach?
  • Is the use of vaginal mesh as safe as abdominal mesh?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized non-inferiority study designed to compare the objective outcomes of treating apical compartment pelvic organ prolapse (POP) using robot-assisted abdominal mesh surgery versus vaginal mesh surgery. Additionally, clinical parameters such as mesh erosion, pain, and symptom-specific quality of life will be assessed utilizing an internationally validated instrument adapted for Portuguese-speaking populations.

Patients diagnosed with stage II or higher apical compartment pelvic organ prolapse (POP), with or without a uterus, who require surgical intervention and provide informed consent will be randomized through REDCap® software to determine the surgical approach.

The interventions under investigation include: vaginal prolapse repair with placement of the Splentis® mesh (Promedon®, Córdoba, Argentina) - not FDA approved, comprising anterior colporrhaphy combined with suspension of the cervix or vaginal vault, with bilateral anchoring of the mesh to the sacrospinous ligaments; and robot-assisted laparoscopic abdominal repair employing the Upsylon® mesh (Boston Scientific®, USA) - FDA approved - via colpocervicopexy, involving mesh fixation to the anterior and superior vaginal walls as well as the sacral promontory.

The sample size was calculated to assess the non-inferiority of the vaginal approach compared with the abdominal approach. Assuming an objective cure rate (stage 0 or I) of 90% for the abdominal group and 80% for the vaginal group, with a two-sided significance level of p < 0.05 and an anticipated loss to follow-up of up to 10% in each group, a minimum of 43 participants per arm (total of 86 patients) was required. The calculation was based on detecting a non-inferiority margin considered clinically acceptable for the primary outcome.

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403000
        • Recruiting
        • Hospital das Clinicas da Faculdade de Medicina de Sao Paulo
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Luccas Soares Laferreira, MD
        • Principal Investigator:
          • Marcelo Hisano, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.

Exclusion Criteria:

  • The following exclusion criteria will apply: patients who are unable or unwilling to complete validated outcome assessment instruments; those requiring concomitant surgical procedures (e.g., hysterectomy or any other intervention that may alter pelvic floor anatomy);
  • individuals with a prior history of pelvic radiotherapy;
  • patients with congenital or acquired anomalies of the urogenital or gastrointestinal systems;
  • and those with medical conditions that constitute a contraindication to elective surgical intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaginal mesh surgery
Vaginal mesh surgery for apical prolapse
Procedure: Vaginal mesh surgery for apical prolapse
Cirurgia com tela vaginal para prolapso apical.
Active Comparator: Robotic-assited abdominal sacrocolpopexy
Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
Procedure: Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
Cirurgia robótica assistida por tela abdominal com dispositivo Upsylon (Boston Scientific - EUA) para prolapso apical vaginal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Cure Rate
Time Frame: Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.
The criteria for objective cure will be defined according to the Pelvic Organ Prolapse Quantification (POP-Q) system, with point C positioned at -6 cm or higher (proximal), corresponding to stage 0 or I genital prolapse.
Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical complication
Time Frame: Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.
Complications will be evaluated in the perioperative period and during follow-up, encompassing surgical complications, long-term adverse events such as mesh erosion, and complications necessitating corrective interventions. These complications will be categorized according to the Clavien-Dindo classification system.
Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7.815.545
  • 86242424.1.0000.0068 (Registry Identifier: CAAE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol; Statistical Analysis Plan (SAP)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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